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Recruiting NCT04298125

Community Translation of the Expecting Study

No phase Interventional Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise in Pregnancy.
Who it may be relevant to
Registry conditions: Pregnancy Related. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D

Overview

The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

Detailed description

The aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based Expecting intervention with pregnant women with obesity in community settings. Specifically, the investigators will show effective application of the Replicating Effective Programs (REP) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. REP provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. Built into the REP framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. The investigators will randomize half to receive the community-adapted Expecting intervention (Intervention, N=30) and half to receive standard of care (Control, N=30).

Interventions

  • Behavioral Exercise in Pregnancy
    Women in this group will participate in psychical activity 3 times per week in their community setting.

Primary outcome measures

  • Feasibility of Intervention Measure:38 weeks [Time frame: 38 weeks]
  • Acceptability of Intervention Measure: 38 weeks [Time frame: 38 weeks]
Secondary outcome measures (5)
  • Number of intervention sessions completed [Time frame: 15 weeks through 38 weeks]
  • Number of minutes of physical activity [Time frame: Change from Baseline to Delivery and 6 Months Post Delivery]
  • Body Mass Index [Time frame: Change from Baseline to Delivery and 6 Months Post Delivery]
  • Blood Pressure [Time frame: Change from Baseline to Delivery and 6 Months Post Delivery]
  • Total Cholesterol from Lipid Panel [Time frame: Change from Baseline to Delivery and 6 Months Post Delivery]

Eligibility criteria

Inclusion criteria

  • (a) Body Mass Index > 30,
  • (b) singleton pregnancy,
  • (c) between 11-15 weeks of pregnancy (at enrollment),
  • (d) Do not currently meet recommended guidelines of 150 min of activity per week
  • (e) cleared by physician

Exclusion criteria

  • (a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)
  • (b) illicit drug use.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Arkansas Children's Nutrition Center — Little Rock

Publications

  • Swindle T, Martinez A, Borsheim E, Andres A. Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol. BMJ Open. 2020 Sep 6;10(9):e038582. doi: 10.1136/bmjopen-2020-038582. PMID 32895286

Identifiers

NCT: NCT04298125 · 260132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗